NDC 0641-6113-01 - Adenosine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0641-6113
Requested NDC: 0641-6113-01
Package NDCs from labels: 0641-6113-01, 0641-6113-10
Manufacturer: Hikma Pharmaceuticals USA Inc. | BAXTER PHARMACEUTICAL SOLUTIONS, LLC
Effective date: 2019-12-30
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
WATER - Hikma Pharmaceuticals USA Inc. \| BAXTER PHARMACEUTICAL SOLUTIONS, LLC	Hikma Pharmaceuticals USA Inc. \| BAXTER PHARMACEUTICAL SOLUTIONS, LLC	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0641-6113-10	2024-01-30	C162847	48780-1	1030e365-4071-111a-e063-dadaa90a10e2	Adenosine Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6113-01	Adenosine	2 mL in 1 VIAL	INJECTION	2		2
0641-6113-10	Adenosine	10 in 1 CARTON	INJECTION	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6113	ADENOSINE INJECTION [HIKMA PHARMACEUTICALS USA INC.]	2	Legacy NDC, 2 package rows	20191231_b827e3f8-dd63-4e54-90f4-0eded943de9f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6113-01	ML - Milliliter	0641-6113	c844132b-68f5-4289-9357-9946cbe62a42	1	2012-07-24
0641-6113-10	ML - Milliliter	0641-6113	3408c2d6-3518-413e-9252-f41ba909d4ae	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ADENOSINE	ACTIVE INGREDIENT	K72T3FS567	ADENOSINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
ADENOSINE	ACTIVE MOIETY	K72T3FS567	ADENOSINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ADENOSINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ADENOSINE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 54 of 54 · 1,063 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
TIS-U-SOL	SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE	Baxter Healthcare Corporation	9da4121f-d62d-4da4-8dfb-0494da16015f	2014-02-21	Exact identifier unii: 451W47IQ8X
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,	Baxter Healthcare Corporation	e1953d54-818d-46a6-8532-518ebae6d84e	2012-06-13	Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.